Prescription medicine
Delafloxacin Brand names: Baxdela
Delafloxacin (Baxdela) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the delafloxacin FDA label on DailyMed (effective August 1, 2025, Melinta Therapeutics, LLC); the NDA 208610 record on Drugs@FDA; every delafloxacin label on DailyMed.
Highlights of the record
FDA label of August 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM.
EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including: Tendinitis and tendon rupture (5.2) Peripheral neuropathy (5.3) Central nervous system effects (5.4) Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions (5.1) Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis. (5.5) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS, and EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning. Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: Tendinitis and tendon rupture ( 5.2 ) Peripheral neuropathy ( 5.3 ) Central nervous system effects ( 5.4 ) Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions. […]
Used for
From the label: indications and usageBAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ( 1.1 ) Community-Acquired Bacterial Pneumonia (CABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be
Forms and strengths
- 450 mg
- 300 mg/10.5ml
Injection (powder) (lyophilized) for solution; tablet.
On the market
- Earliest approval on file
- June 19, 2017 Baxdela, Melinta; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 19, 2031 Baxdela tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 240 through July 30, 2026
What is delafloxacin used for?
From the label: indications and usageBAXDELA is a fluoroquinolone antibacterial indicated for the treatment of adults with the following infections caused by designated susceptible bacteria: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ( 1.1 ) Community-Acquired Bacterial Pneumonia (CABP) ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of BAXDELA and other antibacterial drugs, BAXDELA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]
FDA pharmacologic class: Fluoroquinolone Antibacterial.
Source: FDA drug label (Baxdela), Melinta Therapeutics, LLC, effective August 1, 2025 (SPL set fb77637a-88d9-4aea-958f-e270030ce30d), via openFDA; the full label on DailyMed
What does the patient leaflet for delafloxacin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BAXDELA?BAXDELA, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you get any of the following serious side effects while you take BAXDELA, you should stop taking BAXDELA immediately and get medical help right away. 1. Tendon rupture or swelling of the tendon (tendinitis). Tendon problems can happen in people of all ages who take BAXDELA . Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. The risk of getting tendon problems while you take BAXDELA is higher if you: are over 60 years of age are taking steroids (corticosteroids) have had a kidney, heart or lung transplant Tendon problems can happen in people who do not have the above risk factors when they take BAXDELA. […] Stop taking BAXDELA immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: hear or feel a snap or pop in a tendon area bruising right after an injury in a tendon area unable to move the affected area or bear weight 2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including BAXDELA. […]
From the patient leaflet: What should I avoid while taking BAXDELA?BAXDELA can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how BAXDELA affects you.
From the patient leaflet: How should I store BAXDELA?BAXDELA Tablets: Store BAXDELA Tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep BAXDELA away from moisture (humidity). Keep BAXDELA and all medicines out of the reach of children.
Source: FDA drug label (Baxdela), Melinta Therapeutics, LLC, effective August 1, 2025 (SPL set fb77637a-88d9-4aea-958f-e270030ce30d), via openFDA; the full label on DailyMed
Is there a generic for delafloxacin (Baxdela)?
No generic delafloxacin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Baxdela tablets: the compound patent runs to June 19, 2031; a patent listed only for Baxdela injection runs to June 2, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the delafloxacin label say about other medicines?
The delafloxacin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Glyburide | warnings and precautions | Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. |
| Sucralfate | drug interactions | Oral administration of BAXDELA with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder … |
Source: FDA drug label (Baxdela), Melinta Therapeutics, LLC, effective August 1, 2025 (SPL set fb77637a-88d9-4aea-958f-e270030ce30d), via openFDA; the full label on DailyMed
What do FAERS reports show for delafloxacin?
The FDA Adverse Event Reporting System holds 240 reports that list delafloxacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 19 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other fluoroquinolones
- the pharmacologic class, with prices and generics
- Delafloxacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other